Workshop on Vaccine Efficacy & Safety

January 7, 2021 1:30 pm – 3:30 pm EST

Organizing Committee:

Juergen Richt, CEEZAD Center, Kansas State University (Chair)

Fred Roberts, CCICADA Center, Rutgers University (co-Chair)



PROGRAM   (*All times are in EST*)

1:30 PM-1:35 PM: Welcome and Opening Remarks:
Dana Saft, DHS Office of University Programs
Juergen Richt, CEEZAD, Kansas State University
Fred Roberts, CCICADA, Rutgers University

1:35 PM-1:55 PM: Keynote
Dr. Florian Krammer, Professor of Vaccinology, Icahn School of Medicine at Mount Sinai   Slides

1:55 PM-2:30 PM: Panel: Vaccine Efficacy and Safety

Moderator: Juergen Richt, CEEZAD, Kansas State University
Panelists:
Dr. Philip Dormitzer, Vice President and Chief Scientific Officer Viral Vaccines, Pfizer   Slides
Dr. Hana Golding, Chief of the Laboratory of Retrovirus at the Division of Viral Products, Center for Biologics Evaluation and Research (CBER), FDA   Slides
Dr. Randy Hyer, SVP, Global Medical Affairs, Moderna
Dr. Fred Cassels, Global Head, Enteric and Diarrheal Diseases, PATH   Slides
Dr. Adolfo Garcia-Sastre, Professor, Departments of Microbiology and Medicine and in the Tisch Cancer Center at Icahn School of Medicine Mount Sinai   Slides
Dr. Karen Makar, Senior Program Officer, Bill & Melinda Gates Foundation   Slides
Dr. Stanley Perlman, Professor of Microbiology and Immunology, and of Pediatrics, University of Iowa   Slides

2:30 PM-3:30 PM: Open discussion with Panelists

Moderator: Juergen Richt, CEEZAD, Kansas State University



Program and Bios:

Introductory Remarks: Dana Saft, DHS Office of University Programs

Bio: Ms. Dana Saft is an experienced program manager with over a decade of combined experience in both the private and public sector managing research and development efforts. Currently she serves as a Program Manager at the Department of Homeland Security’s Science and Technology Directorate, Office of University Programs. In this role, Ms. Saft manages the Critical Infrastructure Resilience Institute a Center of Excellence led by the University of Illinois-Urbana Champaign and the National Counterterrorism Innovation, Technology, and Education (NCITE), a Center of Excellence led by the University of Nebraska at Omaha. Within the Office of University Programs, she also advises leadership on strategic and multi-year planning, conducts analysis on current research and development portfolios to determine potential commercialization pathways, and identifies projects ripe for advanced development and joint collaboration between the Centers of Excellence.

Prior to supporting DHS, Ms. Saft was an Associate at Booz Allen Hamilton where she served as Post-Merger Integration Project Manager for corporate, led and contributed to business development efforts resulting in over $50 million, provided project management support for four University-led Center of Excellences responsible for conducting next generation research in the areas of Food Security, Agriculture Defense, Biodefense, and Critical Infrastructure Resiliency worth a total of $140 million, and managed over 125 technological cost reduction initiatives worth an estimated savings of $1.6 billion as a Design for Affordability Analyst supporting the Naval Sea Systems Command (NAVSEA).

Ms. Saft is currently obtaining her Master in Business Administration at George Washington University. She is a graduate of George Mason University with a Master of Science in Biodefense and from Radford University with a Bachelor of Science in Chemistry Pre-Health.


Introductory Remarks: Fred Roberts, Director, COE COVID-19 Supply Chain Initiative, Director of CCICADA COE

Bio: Fred Roberts
FRED S. ROBERTS is a Distinguished Professor of Mathematics at Rutgers University and Director of the Command, Control, and Interoperability Center for Advanced Data Analysis (CCICADA), founded as a University Center of Excellence of DHS. He is Emeritus Director of DIMACS, one of the original National Science Foundation science and technology centers, with 14 academic and industrial partners and some 350 affiliated scientists. Among his current research interests are resilience of supply chains, challenges of disasters and pandemics, stadium and large venue security, resource allocation, maritime cyber security, and the homeland security aspects of global environmental change. Roberts has authored four books, edited 24 additional books, and authored 200 scientific articles, some translated into Russian and Chinese, included the first book on maritime cyber security. Among his awards are the Commemorative Medal of the Union of Czech Mathematicians and Physicists, the Distinguished Service Award of the Association of Computing Machinery Special Interest Group on Algorithms and Computation Theory, Fellow of the American Mathematical Society, the National Science Foundation Science and Technology Centers Pioneer Award, and an honorary doctorate from the University of Paris-Dauphine.


Introductory Remarks: Juergen Richt, Director,  Director of CEEZAD COE

Bio: Juergen A. Richt, DVM, PhD
Dr. Richt came to Kansas State University in 2008 as The Regents Distinguished Professor and Kansas Bioscience Eminent Scholar. In 2010, he became Director of the Department of Homeland Security (DHS) Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and in 2020 Director of the National Institutes of Health (NIH) Center on Emerging and Zoonotic Infectious Diseases (CEZID). He received his Doctorate in Veterinary Medicine (DVM) from the University of Munich and a PhD in Virology and Immunology from the University of Giessen, both in Germany. After coming to the United States in 1989, he completed three years of postdoctoral/residency studies at The Johns Hopkins University and later served for eight years as a Veterinary Medical Officer at the National Animal Disease Center (USDA-ARS) in Ames, Iowa. He has edited several books, published more than 250 peer-reviewed manuscripts and raised more than $50 million in grants for veterinary research.

Dr. Richt is a pioneer in veterinary science, most notably in the “One Health” field.  His work on high consequence pathogens with zoonotic and transboundary potential led to strategies to identify, control and/or eradicate such agents. His basic and applied research includes studies on animal influenza viruses, animal prion diseases including bovine spongiform encephalopathy (BSE), Rift Valley Fever virus (RVFV), African Swine fever virus (ASFV) and Borna Disease virus (BDV). Dr. Richt established the first reverse genetics system for swine influenza virus (SIV), and made seminal contributions to the development of a modified live SIV vaccine now sold in the U.S. as “Ingelvac Provenza™” and to understanding the virulence of the reconstructed 1918 “Spanish Flu” virus in livestock. He identified an atypical BSE case with a causative mutation (“genetic BSE”), used gene-editing approaches to develop the first prion protein knock-out cattle which are resistant to prion infection, and provided valuable information on host range of animal prions essential for risk analysis. Dr. Richt’s RVFV work led to the development of novel domestic and wild ruminant models for RVF and a safe, efficacious, and DIVA compatible subunit vaccine which is presently undergoing USDA licensure. For ASFV, he is developing subunit and modified live virus vaccine candidates as well as Point-of- Need diagnostics (PenCheckTM) to protect swine from this devastating disease. His recent work focused on the establishment of preclinical animal models for COVID-19 in cats, hamsters and ferrets. As founding Director of the DHS CEEZAD and the NIH CEZID Centers, he is supporting NIH, DHS and USDA in protecting public health and U.S. agricultural systems from devastating animal and zoonotic diseases.



Confirmed Speakers:

Keynote: Florian Krammer, Mt. Sinai School of Medicine

Slides   Bio: Florian Krammer, PhD, graduated from the University of Natural Resources and Life Sciences, Vienna (Austria) in 2010. He received his postdoctoral training in the laboratory of Dr. Peter Palese at the Icahn School of Medicine at Mount Sinai, New York working on hemagglutinin stalk-based immunity and universal influenza virus vaccines. In 2014 he became an independent principal investigator and is currently Mount Sinai Professor of Vaccinology at the Icahn School of Medicine at Mount Sinai. Dr. Krammer’s work focuses on understanding the mechanisms of interactions between antibodies and viral surface glycoproteins and on translating this work into novel, broadly protective vaccines and therapeutics. The main target is influenza virus but he is also working on coronaviruses, flaviviruses, hantaviruses, filoviruses and arenaviruses.



Panelists:

Fred Cassels, PATH

Slides   Bio: Fred Cassels, leads the Enteric and Diarrheal Diseases (EDD) division (since 2016), which focuses on rotavirus, polio, Shigella, and enterotoxigenic E. coli (ETEC) vaccines, while also heading up the COVID-19 Initiative Team, all within the Center for Vaccine Innovation and Access (CVIA) at PATH.  EDD/CVIA projects range from vaccine discovery, generation of in vitro and in vivo proof of concept, cGMP manufacture, phase 1-4 clinical trials, licensure in country and through the WHO, and includes country introduction of vaccines, for the benefit of low and middle income countries.  Fred previously served in the role of Chief of the Enteric and Hepatic Diseases Branch (2011-2016), Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases, National Institutes of Health.  The work there encompassed the management of grants, preclinical product development and vaccine manufacturing contracts, as well as domestic and international clinical trials.  Also while at DMID, Fred served as the Severe Acute Respiratory Syndrome (SARS) and Influenza Vaccines Program Officer (2004-2011).  Prior to DMID, he worked in the Department of Enteric Infections, Walter Reed Army Institute of Research (1988-2004), developing ETEC vaccine candidates and delivery technologies, and testing them preclinically and in phase 1 human trials.


Philip Dormitzer, M.D, Ph.D. Vice President and Chief Scientific Officer Viral Vaccines, Pfizer

Slides   Bio: Dr. Dormitzer leads Pfizer viral vaccines research and development programs. These programs include the Pfizer-BioNTech RNA-based COVID-19 pandemic vaccine and influenza vaccine collaborations. The COVID-19 vaccine has been authorized for emergency use, and mass vaccination campaigns have begun. A prefusion F-based RSV vaccine to protect infants through maternal immunization has been advanced from discovery to a global phase 3 clinical trial in pregnant women. A cytomegalovirus vaccine candidate is preclinical. Before joining Pfizer, Dr. Dormitzer held positions at Novartis Vaccines that included Head of US Research.  He was the founding member of the Novartis Viral Vaccine Research Center in Cambridge, MA.  In 2009, his research team supported the development and licensure of three H1N1v influenza pandemic vaccines in the most rapid vaccine response in history, prior to the current COVID-19 pandemic.  In 2013, his team responded to the H7N9 influenza outbreak by supplying the US pre-pandemic stockpile with a vaccine generated from a synthesized virus.  Before joining industry, Dr. Dormitzer was an Assistant Professor of Pediatrics at Harvard Medical School and led a structural virology laboratory, which, with collaborators, determined the structures of the rotavirus neutralization antigens.  He graduated summa cum laude in Anthropology from Harvard College; conducted paleontological research in Pakistan and studied the Efe Pygmies in Zaire; obtained a Ph.D. in Cancer Biology and an MD at Stanford University; completed Internal Medicine training at Massachusetts General Hospital; and completed the Harvard Infectious Diseases Program clinical fellowship.


Adolfo Garcia-Sastre, Mt Sinai School of Medicine

Slides   Bio: Adolfo Garcia-Sastre is Professor in the Departments of Microbiology and Medicine and in the Tisch Cancer Center at Icahn School of Medicine Mount Sinai (ISMMS) in New York. He is also Director of the Global Health and Emerging Pathogens Institute at ISMMS, and Principal Investigator for the Center for Research on Influenza Pathogenesis (CRIP), one of five NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS). For the past 30 years, his research interest has been focused on the molecular biology, virus-host interactions, innate immunity and pathogenesis of influenza viruses and several other RNA viruses, as well as on the development of new vaccines and antivirals. He has more than 500 peer-reviewed publications in these areas of research. He has been President of the International Society for Vaccines in 2014-2015. He is Editor for the scientific journals PLoS Pathogens, Journal of Virology and Virus Research. In 2017, he has been elected a fellow of the Royal Academy of Pharmacy in Spain. In 2019, he was recognized with a Honorary Doctor Degree from the University of Burgos, Spain. Also in 2019, he was elected a member of the National Academy of Sciences and of the National Academy of Inventors.


Hana Golding, Center for Biologics Evaluation and Research, FDA

Slides   Bio: Hana Golding is the Chief of the Laboratory of Retrovirus at the Division of Viral Products, Center for Biologics Evaluation and Research (CBER), FDA. Dr. Golding received her Ph.D. degree from Oregon Health Sciences University, Oregon, and her postdoctoral training at the Experimental Immunology Branch, NCI, NIH. Dr. Golding Joined the Division of Viral Products, CBER in 1987 and was assigned as the Chief of the Laboratory of Retrovirus Research in 1993. Dr. Golding has authored more than 200 research papers and book chapters on immunology, virology, and infectious diseases topics.

The main areas of research projects in the Golding lab:
– Vaccines against viral pathogens including pandemic Influenza, RSV, Ebola, Zika, HIV, and SARS-CoV-2:
– Evaluation of vaccine safety (in vivo/in vitro) and immune responses, including new methods for antibody avidity and epitope diversity.
– Vaccine Adjuvants: their mode of action, impact on immune responses, and new biomarkers predictive of their safety and efficacy in humans.


Randall N. Hyer, MD, PhD, MPH, Senior Vice President, Global Medical Affairs, Moderna

Bio: Dr. Hyer has over three decades of experience in medicine and public health in both the public and private sectors.  After graduating with distinction from the US Naval Academy, he studied at Duke Medical School and then earned the PhD in molecular biology from Oxford University.  He then spent 13 months on the “ice” in Antarctica as the Station Physician for the winter.  Dr. Hyer then shifted to public health and vaccines, serving four years at the World Health Organization as a medical officer responding to outbreaks and emergencies including anthrax, Ebola, SARS, avian influenza, as well as tsunamis and earthquakes.  In response to the need for effective communication, Randy co-authored a popular WHO handbook on risk and crisis communication during public health emergencies.  In industry, Randy’s experience covers vaccines, biologics, biosimilars, and small molecule development.  He was pivotal to the 2017 approval of a two-dose adult hepatitis B vaccine (HEPLISAV-B), the first FDA approved vaccine with a truly novel adjuvant.  Beyond development, his responsibilities have included directing vaccine and pharmaceutical safety programs, overseeing vaccine clinical operations and biometrics functions, engaging medical scientists and policy-makers, and managing crises.  Randy’s perspectives and contributions span his residing in eight and traveling to 100 plus countries in diverse roles across the public and private sectors.


Karen Makar, Gates Foundation

Slides   Bio: Dr. Karen Makar is a PhD immunologist with expertise in molecular epidemiology, clinical immune monitoring and biomarker discovery. As a Senior Program Officer on the Vaccine Discovery & Human Immunobiology team at the Bill & Melinda Gates Foundation, she leads an immune correlates initiative which identifies and prioritizes immune correlates activities for the foundation’s invested vaccines to accelerate the discovery, development, and licensure of effective vaccines for BMGF target populations in low and middle income countries. In 2014, she launched the Global Health – Vaccine Accelerator Platforms (GH-VAP) program to connect foundation grantees with high quality, cutting edge research platforms. GH-VAP has grown to over 200 projects across 14 platforms serving more than a dozen different disease areas. Previously, she served as Director of the Molecular Epidemiology Laboratory at Fred Hutchinson Cancer Research Center and worked in industry as a Vaccine Development Scientist evaluating therapeutic cancer vaccines.


Stanley Perlman, The University of Iowa, Professor of Microbiology and Immunology, and of Pediatrics

Slides   Bio: Dr. Stanley Perlman received his Ph.D. in Biophysics from M.I.T., Cambridge, Massachusetts and his M.D. from the University of Miami, Miami, Florida. He was trained in Pediatrics and Pediatric Infectious Diseases at Boston Children’s Hospital, Boston, Massachusetts. His current research efforts are focused on coronavirus pathogenesis, including virus-induced demyelination and the Severe Acute Respiratory Syndrome (SARS), the Middle East Respiratory Syndrome (MERS) and COVID-19.

His laboratory has developed several novel animal models useful for studying pathogenesis and evaluating vaccines and anti-viral therapies. His studies are directed at understanding why aged patients and mice developed more severe disease than younger individuals after infection with SARS-CoV or SARS-CoV-2 and also on why there is a male predominance in patients with more severe disease after infection with SARS-CoV, MERS-CoV or SARS-CoV-2. He and his colleagues demonstrated that transduction of mice with an adenovirus expressing the human receptor for MERS-CoV, DPP4, rendered them sensitive to infection, providing the first rodent model useful for studying MERS. Similar approaches have been used to develop a mouse model for COVID-19. He has also developed models for the loss of sense of smell (anosmia) observed in patients with COVID-19.


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